Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-H3733 Liquid Dosage Form · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form | EXPERIMENTAL | A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: SAD Cohorts 1-7 Placebo Liquid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form | EXPERIMENTAL | Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 Placebo Liquid Form | PLACEBO_COMPARATOR | Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form | EXPERIMENTAL | A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form | EXPERIMENTAL | A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 Placebo Solid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Name | Type | Description |
|---|---|---|
| ABI-H3733 Liquid Oral Dosage Form | DRUG | ABI-H3733 liquid oral dosage form |
| ABI-H3733 Solid Oral Dosage Form | DRUG | ABI-H3733 solid oral dosage form |
| Placebo to ABI-H3733 Liquid Oral Dosage Form | DRUG | Placebo to ABI-H3733 liquid oral dosage form |
| Placebo to ABI-H3733 Solid Oral Dosage Form | DRUG | Placebo to ABI-H3733 solid oral dosage form |
Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. Exclusion Criteria: * Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C. * History of or current persistent drug or alco...
ABI-H3733 Liquid Dosage Form is an investigational small molecule being developed for the treatment of Chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ABI-H3733 Liquid Dosage Form is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ASMB.
ABI-H3733 Liquid Dosage Form is in Phase 1 clinical development. It is an investigational drug and has not been approved for commercial use.
ABI-H3733 Liquid Dosage Form has one completed Phase 1 clinical trial, NCT04271592, which assessed its safety, tolerability, and pharmacokinetics in healthy adults. The trial enrolled 120 participants in New Zealand.
ABI-H3733 Liquid Dosage Form is a specific liquid formulation of the drug candidate ABI-H3733. The clinical trial NCT04271592 evaluated this liquid dosage form in healthy volunteers.